相关临床试验
80
26 进行中
药物批准
283
批准总数
监管机构
6
监管机构数
成立时间
N/A
进行中（未招募）
6
7.5%
已完成
42
52.5%
尚未招募
20
25.0%
招募中
9
11.3%
Unknown
3
3.8%
- Patent lawsuits involving blockbuster pharmaceutical products including Novo Nordisk's weight-loss drug Wegovy and COVID-19 vaccine delivery technologies are scheduled for trial in 2026. - Novo Nordisk's lawsuit against Viatris' Mylan unit seeking to block generic copies of Wegovy has a bench trial set to begin March 2 in Delaware federal court. - This case represents among the first patent suits over GLP-1 weight-loss treatments to reach trial, marking a significant milestone for the rapidly growing obesity medication market.
- Sandoz reached a settlement agreement with Regeneron allowing launch of ENZEEVU (aflibercept-abzv) biosimilar in the fourth quarter of 2026. - Formycon settled its BPCIA litigation with Regeneron, resulting in dismissal of all claims and vacation of the preliminary injunction against AHZANTIVE (aflibercept-mrbb). - The settlements are part of ongoing multi-district litigation involving multiple biosimilar developers challenging Regeneron's aflibercept patents for neovascular age-related macular degeneration treatment.
- Major pharmaceutical companies including AstraZeneca, Novartis, and Astellas are defending patents for blockbuster drugs like Lynparza, Entresto, and Xtandi against generic manufacturers in early 2025. - The wave of Abbreviated New Drug Application (ANDA) cases spans critical therapeutic areas including oncology, cardiovascular disease, and neurological disorders. - Patent litigation activity has intensified with over 100 new cases filed across multiple federal district courts, indicating significant generic competition pressure on brand-name drugs.
- The FDA quietly permitted more than 150 exempted products from officially banned foreign factories to continue shipping to the United States for over a dozen years to prevent drug shortages. - ProPublica's investigation revealed that most exempted drugs came from factories in India, with additional facilities in China and Hungary, despite dangerous manufacturing failures that led to import bans. - The agency did not regularly test these exempted drugs or proactively monitor safety reports describing products with foul odors, abnormal taste, or consumers experiencing unexplained health problems. - Several factories remain banned but continue receiving exemptions, while the FDA kept this practice largely hidden from the public without releasing a comprehensive list until now.
- The EpiPen patent held by Viatris expires on September 11, 2025, ending years of market protection that limited alternatives for emergency epinephrine delivery devices. - Generic competitors will gain access to EpiPen's patented spring-loaded mechanism, potentially leading to lower prices and improved accessibility for patients requiring life-saving allergy treatment. - The patent expiration enables innovation opportunities including enhanced ergonomics, digital health integrations, and alternative delivery methods while leveraging the established design for regulatory efficiency. - Viatris faces pressure to reduce prices or develop next-generation devices to maintain market share amid increased competition from generic manufacturers.
- The European General Court overturned a European Commission decision that would have extended Biogen's market exclusivity for Tecfidera from ten to eleven years, ruling that strict eight-year deadlines cannot be extended due to case complexity. - The court's ruling establishes that generic drug manufacturers need clarity on market entry timelines and that regulatory authorities cannot exercise discretion to bypass statutory time limits under Article 14(11) of Regulation 726/2004. - Biogen continues to fight multiple patent disputes across European countries including Germany, Netherlands, and France through preliminary injunction proceedings to protect its formulation patent EP 2 653 873 covering dimethyl fumarate compositions. - The additional year of market protection had already expired in February 2025, though the ruling may open the door for generic manufacturers like Mylan and Viatris to pursue damages claims.
- Regeneron filed a new patent infringement complaint against Amgen on June 17, 2025, asserting U.S. Patent No. 12,331,099 covering a stable liquid ophthalmic formulation without buffer requirements. - The Patent Trial and Appeal Board denied inter partes review petitions from Samsung Bioepis and Formycon challenging Regeneron's earlier aflibercept patent, citing substantial investment in parallel district court proceedings. - Amgen's biosimilar PAVBLU launched commercially in November 2024 after the Federal Circuit denied Regeneron's preliminary injunction motion on a separate patent covering buffered formulations.
- Viatris plans to file its fast-acting meloxicam formulation for FDA approval this year, targeting acute pain management based on positive Phase III data in post-surgical settings. - The submission comes seven years after Viatris acquired the meloxicam formulation, representing a significant advancement in the company's pain management portfolio. - Clinical trials demonstrated the drug's efficacy in post-surgical pain scenarios, potentially offering healthcare providers a new option for acute pain treatment.
- A new sustained-release formulation of flucytosine for cryptococcal meningitis has entered Phase II trials in Malawi and Tanzania, simplifying dosing from four times to twice daily and improving administration options. - Cryptococcal meningitis, the second leading cause of death in patients with advanced HIV after tuberculosis, killed approximately 130,000 people in Africa in 2023 alone. - Recent HIV funding cuts threaten to reverse decades of progress, with experts warning of imminent stockouts of essential medicines like flucytosine and disruptions to advanced HIV disease services.
- The Patent Trial and Appeal Board (PTAB) has issued multiple final written decisions finding Regeneron's aflibercept-dosing patents for EYLEA unpatentable, with Regeneron voluntarily dismissing several Federal Circuit appeals. - Samsung Bioepis's EYLEA biosimilar Opuviz received FDA approval as an interchangeable biosimilar on May 20, 2024, but faces a preliminary injunction preventing commercial launch. - The patent invalidations affect key intellectual property protecting EYLEA, which generated $5.89 billion in sales for Regeneron in 2023, signaling potential increased biosimilar competition.
